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Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI

Primary Purpose

Survival Myocardial Area After Acute Myocardial Death, Left Ventricular Ejection Fraction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cardiomyopeptidin
Sponsored by
Dalian Zhen-Ao Bio-Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Survival Myocardial Area After Acute Myocardial Death focused on measuring Acute myocardial infarction, Nuclear magnetic image, Survival myocardial area

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) Sign the informed consent form;
  • 2) Age ≥ 18 and ≤ 80 years old, gender is not limited;
  • 3) Defining the diagnosis of acute myocardial infarction, with indications for direct coronary intervention;
  • 4) Ischemic chest pain lasts for more than 30 minutes and adjacent ST or 2 leads of more than 2 or more leads (limb lead ≥ 0.1 mV, chest lead ≥ 0.2 mV) with or without elevated myocardial enzyme levels ;
  • 5) The course of disease is ≤12 hours or accompanied by cardiogenic shock or heart failure (onset >12h).

Exclusion Criteria:

  • (1) Cardiogenic shock, Killip III-IV grade, papillary muscle rupture, interventricular septal perforation, ventricular ventricular fibrillation and electrical cardioversion, and III degree AVB implantation of temporary pacemaker before PCI;
  • (2) LVEF ≤ 30%;
  • (3) Previous history of PCI and CABG history;
  • (4) acute and chronic infectious diseases (severe pneumonia, etc.);
  • (5) Recent history of hemorrhagic stroke (within six months);
  • (6) Combining liver and kidney dysfunction caused by various reasons;
  • (7) History of valvular heart disease;
  • (8) Congenital heart disease and pulmonary hypertension;
  • (9) History of various types of cardiomyopathy;
  • (10) bleeding and other thrombotic diseases;
  • (11) severe anemia, thrombocytopenia and other blood system diseases;
  • (12) Patients with malignant tumors, autoimmune diseases, and various causes of glucocorticoids and immunosuppressive agents;
  • (13) Patients with a history of drug allergy, allergic diseases or allergies, or patients who are allergic to any of the ingredients in this product;
  • (14) Patients with severe mental or neurological diseases;
  • (15) pregnant women, lactating women, and subjects with a pregnancy plan during the trial;
  • (16) According to the investigator's judgment, the subject is unable to complete the study or may not be able to comply (for administrative reasons or other reasons) the subjects required for this study.
  • (17) Patients who have participated in other clinical trials in the past 3 months.Researchers believe that it is not appropriate to participate in this clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Myocardin test group

    Blank test group

    Arm Description

    Patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI.

    Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) .

    Outcomes

    Primary Outcome Measures

    Myocardial infarct size
    Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;

    Secondary Outcome Measures

    Delay enhancement
    Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement
    ECG ST-T changes
    Interpretation of ST-T changes in leads based on electrocardiogram
    Heart function classification
    Cardiac function grading of patients with acute myocardial infarction by Killip grading
    CK（ng/ml）
    one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml)
    CK-MB(ng/ml)
    one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml)
    cTnT(ng/ml)
    one of Myocardial enzymes
    BNP(pg/ml)
    one of Myocardial enzymes
    Cardiac echocardiography
    Left ventricular ejection fraction
    Incidence of cardiovascular events
    Non-lethal myocardial infarction, all-cause death, revascularization due to angina pectoris, re-hospitalization of acute heart failure

    Full Information

    First Posted
    April 18, 2019
    Last Updated
    May 19, 2019
    Sponsor
    Dalian Zhen-Ao Bio-Tech Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03958422
    Brief Title
    Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI
    Official Title
    A Randomized, Single-blind, Controlled Clinical Trial of Cardiomyopeptidin Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Direct PCI After Ischemia-reperfusion Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    November 30, 2019 (Anticipated)
    Study Completion Date
    January 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dalian Zhen-Ao Bio-Tech Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In this study, advanced techniques of myocardial nuclear magnetic perfusion scanning were used to quantitatively assess infarct size after acute myocardial infarction, saved viable myocardium, and microcirculatory obstruction area. Objectively and quantitatively evaluate early use of cardiomyopeptidin for direct PCI of ST-segment elevation myocardial infarction. After the improvement of microcirculation and increase the intervention effect of viable myocardium.
    Detailed Description
    This is a prospective, randomized, controlled, single-blind, single-center clinical trial. Patients with ST-segment elevation myocardial infarction (STEMI) who were admitted in the People's Liberation Army General Hospital were equally randomized to receive either cardiomyopeptidin or placebo, and patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI. Myocardial perfusion flow grade was evaluated by the result of primary PCI. Myocardial infarct size, microvascular obstruction and salvage myocardium were evaluated by enhanced cardiac magnetic resonance (CMR). Major adverse cardiovascular events (nonfatal myocardial infarction, all-cause death, hospitalization for acute heart failure, and revascularization for angina) were observed during the 6-month follow-up. CMR is performed to evaluate the effect of cardiomyopeptidin before primary PCI on myocardial salvage and microcirculation perfusion in patients with STEMI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Survival Myocardial Area After Acute Myocardial Death, Left Ventricular Ejection Fraction
    Keywords
    Acute myocardial infarction, Nuclear magnetic image, Survival myocardial area

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Random, controlled, single blind
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Myocardin test group
    Arm Type
    Experimental
    Arm Description
    Patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI.
    Arm Title
    Blank test group
    Arm Type
    No Intervention
    Arm Description
    Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) .
    Intervention Type
    Drug
    Intervention Name(s)
    cardiomyopeptidin
    Intervention Description
    The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.
    Primary Outcome Measure Information:
    Title
    Myocardial infarct size
    Description
    Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;
    Time Frame
    7±3 days after surgery
    Secondary Outcome Measure Information:
    Title
    Delay enhancement
    Description
    Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement
    Time Frame
    7±3 days after surgery
    Title
    ECG ST-T changes
    Description
    Interpretation of ST-T changes in leads based on electrocardiogram
    Time Frame
    "hour6", "hour12","hour24"after myocardial infarction
    Title
    Heart function classification
    Description
    Cardiac function grading of patients with acute myocardial infarction by Killip grading
    Time Frame
    "day6", "week4","week12","week24"after surgery
    Title
    CK（ng/ml）
    Description
    one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml)
    Time Frame
    "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
    Title
    CK-MB(ng/ml)
    Description
    one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml)
    Time Frame
    "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
    Title
    cTnT(ng/ml)
    Description
    one of Myocardial enzymes
    Time Frame
    "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
    Title
    BNP(pg/ml)
    Description
    one of Myocardial enzymes
    Time Frame
    "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
    Title
    Cardiac echocardiography
    Description
    Left ventricular ejection fraction
    Time Frame
    3days and 1,3,6 monthes after myocardial infarction
    Title
    Incidence of cardiovascular events
    Description
    Non-lethal myocardial infarction, all-cause death, revascularization due to angina pectoris, re-hospitalization of acute heart failure
    Time Frame
    7±3 days and 1,3,6 monthes after myocardial infarction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1) Sign the informed consent form; 2) Age ≥ 18 and ≤ 80 years old, gender is not limited; 3) Defining the diagnosis of acute myocardial infarction, with indications for direct coronary intervention; 4) Ischemic chest pain lasts for more than 30 minutes and adjacent ST or 2 leads of more than 2 or more leads (limb lead ≥ 0.1 mV, chest lead ≥ 0.2 mV) with or without elevated myocardial enzyme levels ; 5) The course of disease is ≤12 hours or accompanied by cardiogenic shock or heart failure (onset >12h). Exclusion Criteria: (1) Cardiogenic shock, Killip III-IV grade, papillary muscle rupture, interventricular septal perforation, ventricular ventricular fibrillation and electrical cardioversion, and III degree AVB implantation of temporary pacemaker before PCI; (2) LVEF ≤ 30%; (3) Previous history of PCI and CABG history; (4) acute and chronic infectious diseases (severe pneumonia, etc.); (5) Recent history of hemorrhagic stroke (within six months); (6) Combining liver and kidney dysfunction caused by various reasons; (7) History of valvular heart disease; (8) Congenital heart disease and pulmonary hypertension; (9) History of various types of cardiomyopathy; (10) bleeding and other thrombotic diseases; (11) severe anemia, thrombocytopenia and other blood system diseases; (12) Patients with malignant tumors, autoimmune diseases, and various causes of glucocorticoids and immunosuppressive agents; (13) Patients with a history of drug allergy, allergic diseases or allergies, or patients who are allergic to any of the ingredients in this product; (14) Patients with severe mental or neurological diseases; (15) pregnant women, lactating women, and subjects with a pregnancy plan during the trial; (16) According to the investigator's judgment, the subject is unable to complete the study or may not be able to comply (for administrative reasons or other reasons) the subjects required for this study. (17) Patients who have participated in other clinical trials in the past 3 months.Researchers believe that it is not appropriate to participate in this clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Geng Qian
    Phone
    13810914587
    Email
    zouzouyuting@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kai Yan
    Phone
    13940849959
    Email
    ykanna_715@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yundai Chen
    Organizational Affiliation
    cardiology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI

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